14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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U by Kotex® Click® Unscented Menstrual Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPEEDTRAP
FDA UDI
Medos International Sàrl·20886705027160·SPEEDTRAP Graft Preparation System WHITE MULTI-...
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
SPEEDTRAP WHITE 30MM 4PK
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code GAT·December 20, 2018
ATLAS PLUS HF CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
PFC SIGMA STAB INS SZ3 12.5MM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 12, 2013
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 27, 2017
SPEEDTRAP WHITE 30MM 4PK
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL·Product code GAT·October 17, 2018
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026